World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. According to antidote.com.

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Clinical Trials Clinical Trials Trials Drugs 187

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7

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Trials Clinical Trials Clinical Trials Gene Therapy 104

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Gene Therapy Clinical Supply Trials Gene 182

Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

SEPTEMBER 18, 2023

Experts say a wider diverse pool of patients needs to be given a chance to participate in clinical trials to get rare disease drugs faster to market.

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Clinical Trials Clinical Trials Trials Marketing 162

Bio Pharma Dive

JULY 9, 2021

Zynteglo sales have been on hold since February, when a patient in a clinical trial of another, related Bluebird medicine developed leukemia.

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Gene Therapy Gene Marketing Clinical Trials 274

Velocity Clinical Research

MARCH 23, 2025

Clinical trials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%

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Clinical Trials Clinical Trials Trials Life Science 52

Antidote

SEPTEMBER 25, 2023

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.

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Clinical Trials Clinical Trials Trials Marketing 128

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

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Trials Clinical Trials Clinical Trials Drugs 189

Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. But how can the patient experience be leveraged to drive your trial’s success?

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Clinical Trials Clinical Trials Trials Clinical Research 147

Imperical Blog

JANUARY 21, 2025

Ive spent my entire adult life immersed in media, marketing, and advertising, long enough to remember the days before digital advertising in clinical trials took over. They… The post Digital Advertising in Clinical Trials: The Real Secret Sauce appeared first on Imperial Clinical Research Services Blog.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Research Clinical Trials Clinical Trials Immune Response 147

Worldwide Clinical Trials

JANUARY 6, 2025

Through the implementation of full automation in bioanalytical testing PK, immunogenicity, and biomarker assays we streamline trials, reduce costs, save time, and maintain the highest data quality standards. Biomarkers support adaptive trial designs, allowing modifications based on interim results to optimize study outcomes.

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Clinical Trials Clinical Trials Trials Genetics 130

XTalks

MARCH 14, 2025

mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.

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Trials Drugs Clinical Trials Clinical Trials 89

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Clinical Trials Clinical Trials Trials Marketing 119

Outsourcing Pharma

NOVEMBER 13, 2024

Driven by the effects of the COVID-19 pandemic, the market for decentralized clinical trials has seen a push that will lead it to more than triple in size within the next decade.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Marketing 100

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Research Clinical Trials Clinical Trials Immune Response 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Clinical Trials Clinical Trials Drugs Regulation 243

Pharmaceutical Technology

JULY 29, 2022

According to GlobalData’s Epidemiology and Market Size database, epidemiologists estimate there are more than 21 million prevalent cases within the tracked 16 countries. Last year saw the most with 167 trials. Cerevel Therapeutics has two Phase II/III trials and three Phase III trials planned.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

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Trials Clinical Trials Clinical Trials Drugs 188

Bio Pharma Dive

FEBRUARY 24, 2025

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

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Clinical Development Development Clinical Trials Clinical Trials 261

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Clinical Development Clinical Trials Clinical Trials Trials 341

World of DTC Marketing

FEBRUARY 15, 2022

Biotechs need to think like marketers to cut through the noise and attract investors. CEOs have to think like marketers to cut through the clutter with all the biotech startups out there. 2wo: Clinical trial data releases need to coincide with major medical conferences.

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Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Trials Clinical Trials Clinical Trials Development 242

Pharmaceutical Technology

NOVEMBER 30, 2022

Gilead Sciences has received the European Commission’s (EC) expanded marketing authorisation for Biktarvy (bictegravir 30mg / emtricitabine 120mg / tenofovir alafenamide 15mg tablets) for treating human immunodeficiency virus (HIV) infection in virologically suppressed children.

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Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Clinical Trials Compliance 204

Outsourcing Pharma

NOVEMBER 13, 2024

Driven by the effects of the COVID-19 pandemic, the market for decentralized clinical trials has seen a push that will lead it to more than triple in size within the next decade.

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Clinical Trials Clinical Trials Marketing Trials 92

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

APRIL 13, 2023

Takeda’s announcement underlines the risk associated with gene therapy R&D at the preclinical stage and the fact that many current AAV programs are unlikely to reach late-stage trials.

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Gene Therapy Marketing Gene In-Vivo 243

Pharmaceutical Technology

MARCH 28, 2023

lower than the previous market day’s close. In December 2022, BioNTech initiated a Phase I clinical trial of BNT163 – an HSV vaccine candidate. In the same month, BioNTech also initiated a Phase I clinical trial (NCT05581641) of the multi-antigen malaria vaccine BNT165b1— the first candidate from the company’s BNT165 program.

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Vaccine Vaccination Development Clinical Trials 276

Cloudbyz

JUNE 9, 2024

In the realm of clinical trials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Clinical Trials Clinical Trials Trials Development 289

XTalks

APRIL 15, 2025

The landscape of rare disease clinical trials has seen significant transformation over the past decade. However, many challenges remain in ensuring patient access, optimizing trial design and leveraging technological advancements to improve outcomes.

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Trials Clinical Trials Clinical Trials Gene Therapy 52

Worldwide Clinical Trials

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Searching for overlap might allow the investigational product to have a more rapid marketing authorization in multiple regions.

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Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.

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Marketing Medicine Production Clinical Trials 264

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Trials Clinical Trials Clinical Trials Production 59